Med Check

Rapastinel Fails Phase 3 Trials

In March Allergan announced that Phase 3 studies of rapastinel as an adjunctive treatment for major depressive disorder (MDD) did not meet its primary endpoints.

In two studies totaling 872 patients with MDD, participants were randomized to 450 mg of rapastinel or placebo given once weekly as a bolus intravenous injection in addition to an oral antidepressant to which the patient had not responded adequately. A similar, third study of 638 participants included a third treatment arm that evaluated a 225 mg dose. The primary endpoint for all three studies was a change in scores on the  Montgomery-Åsberg Depression Rating Scale from baseline and at the end of three weeks. In all three trials, scores for patients receiving rapastinel did not significantly differ from placebo.

Allergan is conducting a global Phase 3 trial to evaluate rapastinel’s efficacy, safety, and tolerability as a monotherapy for MDD compared with placebo. It is also conducting a Phase 2 proof-of-concept study evaluating efficacy, safety, and tolerability of rapastinel compared with placebo in addition to standard of care for patients with MDD at imminent risk of suicide.

FDA to Review NDA for Insomnia Drug

The Food and Drug Administration (FDA) will review a New Drug Application (NDA) submitted for the investigational insomnia drug lemborexant by Eisai Co. Ltd. and Imbrium Therapeutics L.P. The companies announced the forthcoming review in March.

The NDA submission is based on data from two Phase 3 clinical trials in adults with insomnia disorder. SUNRISE 1 evaluated the efficacy and safety of lemborexant versus placebo and versus an active comparator (zolpidem tartrate extended release) in 1,006 patients aged 55 years and older. SUNRISE 2 evaluated the long-term efficacy and safety of lemborexant in 949 patients aged 18 to 88 years. In both studies, lemborexant met its endpoints of improving sleep latency and efficiency.

Lemborexant is thought to work by blunting wakefulness without impeding the ability to awaken in response to external stimuli.

FDA Approves ADHD Drug Adhansia HR

The FDA in February approved Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII for attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older. Adhansia XR is a central nervous system stimulant by Adlon Therapeutics L.P.

Four clinical studies evaluated the efficacy and safety of Adhansia XR in patients with ADHD: two clinical studies in adults, one analog classroom trial in patients aged 6 to 12 years, and one safety and efficacy study in patients aged 12 to 17 years. Patients in all studies achieved statistically significant improvement in symptoms while receiving Adhansia XR compared with placebo.

Adhansia XR will be available later this year in six capsule strengths: 25, 35, 45, 55, 70, and 85 mg. The recommended starting dose for patients 6 years and older is 25 mg once daily, with titration in increments of 10 mg to 15 mg at intervals of no less than five days.

Indivior Launches Perseris for Adults with Schizophrenia

In February Indivior launched Perseris (risperidone) extended-release injectable suspension for treating schizophrenia in adults. Perseris is a once-monthly injection given by a health professional and does not require the patient to take an additional oral medication.

In a Phase 3 study in patients aged 18 to 55 years with acute exacerbations of schizophrenia, both Perseris 90 mg and 120 mg doses met the primary endpoint of change in Positive and Negative Syndrome Scale total score at eight weeks.

For patients who have never taken risperidone, physicians should first establish tolerance with oral risperidone. Perseris may not be right for patients on stable doses of oral risperidone lower than 3 mg or higher than 4 mg a day. ■